Mobility of the Cervical Spine in Patients With Unspecific Neck Pain

NCT06642233 | Active Not Recruiting DMC

• 1 other identifier: KWojniczWUHSS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trials is to describe and correlate the posture, function and disability of the cervical spine in patients with unspecific neck pain. The research hypothesis is: In patients with unspecific neck pain, there is a significant correlation between posture, function and disability of the cervical spine. Participants will take part in functional tests and complete surveys and questionnaires.

Conditions

Manual Therapy; Cervical Spine; Neck Pain

Keywords

manual therapy; cervical spine; neck pain; unspecific neck pain; body composition; functional neck tests; craniovertebral angle; CROM

Outcome Measures

Primary Outcomes (1)

• Cervical Range of Motion

  The CROM (Performance Attainment Associates, Roseville, MN, USA) is a device used to measure degrees of range of motion (ROM) in the cervical spine. The CROM measuring equipment consists of a helmet-shaped structure with the shape of glasses. These glasses adjust to the nasal septum thanks to the velcro on the back to fit them on the head. Three inclinometers for measuring on 3 cardinal planes were placed in the plastic construction. The range of flexion, extension, lateral bending, and rotation will be measured in degrees.

  Baseline

Secondary Outcomes (7)

• Pain intensity

  Baseline

• Quality of Life level

  Baseline

• Degree of Functional Disability

  Baseline

• Physical activity level

  Baseline

• Craniovertebral angle

  Baseline

Study Arms (1)

Women and men aged 18-75

People with a medical diagnosis of unspecific pain in the cervical spine - acute and chronic pain, regardless of when it began.

Diagnostic Test: Socio-demographic survey; Diagnostic Test: Visual Analogue Scale; Diagnostic Test: The World Health Organization Quality-of-Life Scale-BREF questionnaire; Diagnostic Test: The International Physical Activity Questionnaire; Diagnostic Test: The Neck Disability Index questionnaire; Device: Body composition analysis using TANITA device; Diagnostic Test: Cervical spine AROM (Active range of motion); Diagnostic Test: Sagittal plane UCS AROM (Upper cervical spine active range of motion); Diagnostic Test: Flexion-Rotation Test; Diagnostic Test: Sidebending-Rotation Test; Diagnostic Test: Axial rotation test C0-C2; Diagnostic Test: Tilting test C0-C1 and C2-C3; Diagnostic Test: Craniocervical flexion test; Diagnostic Test: Craniovertebral angle

Interventions

Socio-demographic survey DIAGNOSTIC_TEST

Socio-demographic survey includes: age, sex, time of symptoms, work activity, hours of work activity, work position, activities with loads, physical activity, household chores, missing teeth, dental splints, dentures, smoking, alcohol consumption, whether they can reproduce their symptoms, hours during which they perform focal distance tasks, whether they have visual problems, whether they take painkillers or anti-inflammatory drugs, presence of headaches and their frequency), whether you can reproduce your symptoms, hours during which you perform tasks at focal distance, whether you have visual problems, whether you take analgesics or anti-inflammatory drugs, presence and frequency of headaches.

Women and men aged 18-75

Visual Analogue Scale DIAGNOSTIC_TEST

VAS scale - The subject must indicate with a horizontal line their perception of pain on a scale (not numbered) of 100 millimetres, with 0 being the absence of pain and 100 the worst pain imaginable. The patient will complete the VAS scale, responding to the average, maximum and minimum pain experienced throughout its duration.

Women and men aged 18-75

The World Health Organization Quality-of-Life Scale-BREF questionnaire DIAGNOSTIC_TEST

The WHOQOL-BREF questionnaire is used to assess domains quality of life: physical, mental, social functioning and functioning in the environment. Responses are on a 5-point scale (score range 1-5). In each field you can get maximum 20 points. The results of individual areas are positive (the higher the number of points, the higher the quality of life).

Women and men aged 18-75

The International Physical Activity Questionnaire DIAGNOSTIC_TEST

The International Physical Activity Questionnaire (IPAQ) is a self-reported questionnaire for assessing physical activity and sedentary behavior for adults aged 15-69 years, across a range of socio-economic settings.

Women and men aged 18-75

The Neck Disability Index questionnaire DIAGNOSTIC_TEST

The NDI evaluates the effect of neck pain on activities of daily living and social relationships. It consists of 10 items with 6 response options that are scored from 0 to 5 points each for a total possible score of 50. The classification of disability is based on the total score obtained, with higher number indicating greater disability.

Women and men aged 18-75

Body composition analysis using TANITA device DEVICE

TANITA device - body composition analyzer, the proportion of muscle mass and fat in the upper limbs * Body height will be determined using a SECA 217 stadimeter. * General and segmental body composition using the eight-electrode body composition analyzer by TANITA.

Women and men aged 18-75

Cervical spine AROM (Active range of motion) DIAGNOSTIC_TEST

Measurement of cervical spine AROM can be performed using the CROM system (Performance Attainment Associates, Roseville, MN, USA). Flexion, extension, side bending to the right and left, and rotation to the right and left of the cervical spine are examined. The CROM measuring equipment consists of a helmet-shaped structure with the shape of glasses. These glasses adjust to the nasal septum thanks to the velcro on the back to fit them on the head. Three inclinometers for measuring on 3 cardinal planes were placed in the plastic construction.

Women and men aged 18-75

Sagittal plane UCS AROM (Upper cervical spine active range of motion) DIAGNOSTIC_TEST

Measurement of sagittal plane UCS AROM can be performed using the CROM system. Flexion and extension of the upper cervical spine are examined.

Women and men aged 18-75

Flexion-Rotation Test DIAGNOSTIC_TEST

The flexion-rotation test can be performed using the CROM system. Rotation of the upper cervical spine is tested while the cervical spine is flexed.

Women and men aged 18-75

Sidebending-Rotation Test DIAGNOSTIC_TEST

The sidebending-rotation test can be performed using the CROM system. Rotation of the upper cervical spine is tested while the cervical spine is in a lateral tilt.

Women and men aged 18-75

Axial rotation test C0-C2 DIAGNOSTIC_TEST

The Axial rotation test C0-C2 can be performed using the CROM system. Rotation of the C0-C2 is examined.

Women and men aged 18-75

Tilting test C0-C1 and C2-C3 DIAGNOSTIC_TEST

The Tilting test C0-C1 and C2-C3 can be performed using a goniometer. Lateral tilt of the C0-C1 and C2-C3 are examined.

Women and men aged 18-75

Craniocervical flexion test DIAGNOSTIC_TEST

The test measures the level of activation of the deep neck flexors using a pressure biofeedback device, an air-filled manual pressure cuff (Stabilizer TM, Chattanooga Group, INC., USA).

Women and men aged 18-75

Craniovertebral angle DIAGNOSTIC_TEST

The test measure the craniovertebral angle using a telephone placed on a tripod and a computer program. The CVA measurement is defined as the angle a horizontal line passing the neural spine of C7 in relation to the line connecting the tragus and the neural spine of C7.

Women and men aged 18-75

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients applying for individual therapy at the private manual medicine rehabilitation center (Łubinowa street 12/4, 52-210 Wrocław - Poland) and meeting the conditions for inclusion in the study group.

You may qualify if:

• age 18-75 years
• medical diagnosis of non-specific pain in the cervical spine (M54.2 - neck pain) - acute and chronic pain, regardless of when it began
• negative result of cervical spine safety tests
• obtaining written consent to conduct research

You may not qualify if:

• pregnancy
• pacemaker
• active cancer
• no consent to conduct research
• difficulty communicating
• the presence of a metal plate in the head and metal screws in the body
• positive cervical spine safety test
• condition after operations in the area of the cervical spine
• condition after fractures in the cervical spine
• vascular abnormalities and pathologies resulting in symptoms of vertebrobasilar insufficiency (carotid artery occlusion or dissection, vertebral artery insufficiency, emboli)
• contraindications to manual therapy or exercise
• has participated in a cervical spine exercise or manual therapy program in the last three months
• present clear signs of having suffered a significant whiplash injury
• inability to maintain a supine position
• no possibility to perform a flexion-rotation test

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Universidad de Zaragoza: collaborator

Study Sites (1)

Wroclaw University of Health and Sport Sciences

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

Related Publications (12)

• Zarate-Tejero CA, Rodriguez-Rubio PR, Brandt L, Krauss J, Hernandez-Secorun M, Lucha-Lopez O, Hidalgo-Garcia C. Association between Age, Sex and Cervical Spine Sagittal Plane Motion: A Descriptive and Correlational Study in Healthy Volunteers. Life (Basel). 2023 Feb 7;13(2):461. doi: 10.3390/life13020461.

  PMID: 36836818 BACKGROUND

• Zarate-Tejero C, Hidalgo-Garcia C, Lucha-Lopez O, Hernandez-Secorun M, Krauss J, Rodriguez-Rubio P. Association between age, sex and cervical and upper cervical rotation tests. Descriptive and correlational study in healthy volunteers. Ther Adv Chronic Dis. 2023 Apr 29;14:20406223231170158. doi: 10.1177/20406223231170158. eCollection 2023.

  PMID: 37152351 BACKGROUND

• Gallego-Izquierdo T, Arroba-Diaz E, Garcia-Ascoz G, Val-Cano MDA, Pecos-Martin D, Cano-de-la-Cuerda R. Psychometric Proprieties of a Mobile Application to Measure the Craniovertebral Angle a Validation and Reliability Study. Int J Environ Res Public Health. 2020 Sep 8;17(18):6521. doi: 10.3390/ijerph17186521.

  PMID: 32911612 BACKGROUND

• Takasaki H, Hall T, Oshiro S, Kaneko S, Ikemoto Y, Jull G. Normal kinematics of the upper cervical spine during the Flexion-Rotation Test - In vivo measurements using magnetic resonance imaging. Man Ther. 2011 Apr;16(2):167-71. doi: 10.1016/j.math.2010.10.002. Epub 2010 Nov 4.

  PMID: 21055995 BACKGROUND

• Williams MA, McCarthy CJ, Chorti A, Cooke MW, Gates S. A systematic review of reliability and validity studies of methods for measuring active and passive cervical range of motion. J Manipulative Physiol Ther. 2010 Feb;33(2):138-55. doi: 10.1016/j.jmpt.2009.12.009.

  PMID: 20170780 BACKGROUND

• Youdas JW, Garrett TR, Suman VJ, Bogard CL, Hallman HO, Carey JR. Normal range of motion of the cervical spine: an initial goniometric study. Phys Ther. 1992 Nov;72(11):770-80. doi: 10.1093/ptj/72.11.770.

  PMID: 1409874 BACKGROUND

• Kovacs FM, Bago J, Royuela A, Seco J, Gimenez S, Muriel A, Abraira V, Martin JL, Pena JL, Gestoso M, Mufraggi N, Nunez M, Corcoll J, Gomez-Ochoa I, Ramirez MJ, Calvo E, Castillo MD, Marti D, Fuster S, Fernandez C, Gimeno N, Carballo A, Milan A, Vazquez D, Canellas M, Blanco R, Brieva P, Rueda MT, Alvarez L, Del Real MT, Ayerbe J, Gonzalez L, Ginel L, Ortega M, Bernal M, Bolado G, Vidal A, Ausin A, Ramon D, Mir MA, Tomas M, Zamora J, Cano A. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. BMC Musculoskelet Disord. 2008 Apr 9;9:42. doi: 10.1186/1471-2474-9-42.

  PMID: 18400084 BACKGROUND

• Cleland C, Ferguson S, Ellis G, Hunter RF. Validity of the International Physical Activity Questionnaire (IPAQ) for assessing moderate-to-vigorous physical activity and sedentary behaviour of older adults in the United Kingdom. BMC Med Res Methodol. 2018 Dec 22;18(1):176. doi: 10.1186/s12874-018-0642-3.

  PMID: 30577770 BACKGROUND

• Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Corral-de-Toro J, Gonzalez-Rueda V, Lopez-de-Celis C, Perez-Bellmunt A, Hidalgo-Garcia C. Is Cervical Stabilization Exercise Immediately Effective in Patients with Chronic Neck Pain and Upper Cervical Spine Dysfunction? Randomized Controlled Trial. Life (Basel). 2022 May 11;12(5):714. doi: 10.3390/life12050714.

  PMID: 35629381 BACKGROUND

• Sarig Bahat H, Weiss PL, Sprecher E, Krasovsky A, Laufer Y. Do neck kinematics correlate with pain intensity, neck disability or with fear of motion? Man Ther. 2014 Jun;19(3):252-8. doi: 10.1016/j.math.2013.10.006. Epub 2013 Nov 9.

  PMID: 24291364 BACKGROUND

• Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.

  PMID: 20436238 BACKGROUND

• Akodu AK, Akinbo SR, Young QO. Correlation among smartphone addiction, craniovertebral angle, scapular dyskinesis, and selected anthropometric variables in physiotherapy undergraduates. J Taibah Univ Med Sci. 2018 Oct 5;13(6):528-534. doi: 10.1016/j.jtumed.2018.09.001. eCollection 2018 Dec.

  PMID: 31435373 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Katarzyna Wojnicz, Master

  Wroclaw University of Health and Sport Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: October 15, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)